ofatumumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
human origin 4951 679818-59-8

Description:

MoleculeDescription

Synonyms:

  • ofatumumab
  • arzerra
  • GSK1841157
  • HuMax-CD20
  • 2F2
Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.67 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 23, 2021 PMDA Novartis Pharma K.K.
April 19, 2010 EMA Novartis Europharm Ltd
Oct. 26, 2009 FDA GLAXO GRP LTD

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 608.34 18.54 247 13726 52058 90562416
Influenza like illness 344.44 18.54 191 13782 80420 90534054
Expanded disability status scale score increased 315.95 18.54 61 13912 762 90613712
Accidental exposure to product 274.92 18.54 133 13840 42233 90572241
Chills 253.60 18.54 189 13784 131792 90482682
Multiple sclerosis 241.78 18.54 107 13866 27733 90586741
Device malfunction 206.20 18.54 88 13885 20889 90593585
Pyrexia 196.29 18.54 358 13615 660127 89954347
COVID-19 175.78 18.54 170 13803 168673 90445801
Drug dose omission by device 163.67 18.54 61 13912 10170 90604304
Abortion spontaneous 162.12 18.54 102 13871 53954 90560520
Incorrect dose administered by device 152.71 18.54 50 13923 5687 90608787
Maternal exposure during pregnancy 121.77 18.54 207 13766 359856 90254618
Device leakage 115.27 18.54 47 13926 9944 90604530
Product storage error 106.03 18.54 55 13918 20186 90594288
Blood immunoglobulin G decreased 102.97 18.54 33 13940 3505 90610969
Headache 102.43 18.54 328 13645 862418 89752056
Inappropriate schedule of product administration 96.16 18.54 117 13856 149816 90464658
Lymphocyte count decreased 92.36 18.54 61 13912 34989 90579485
Blood immunoglobulin M decreased 84.99 18.54 23 13950 1354 90613120
Hypogammaglobulinaemia 82.99 18.54 38 13935 10636 90603838
Central nervous system lesion 82.90 18.54 39 13934 11607 90602867
Injection related reaction 80.40 18.54 21 13952 1078 90613396
Breast cancer 77.27 18.54 65 13908 53696 90560778
B-lymphocyte count decreased 74.36 18.54 21 13952 1448 90613026
Febrile neutropenia 72.82 18.54 105 13868 158244 90456230
Normal newborn 72.30 18.54 45 13928 23317 90591157
Fatigue 64.43 18.54 348 13625 1153675 89460799
Illness 62.58 18.54 70 13903 81899 90532575
Wrong technique in device usage process 62.38 18.54 26 13947 5809 90608665
Progressive multifocal leukoencephalopathy 61.05 18.54 35 13938 15620 90598854
Needle issue 59.33 18.54 33 13940 13901 90600573
Optic neuritis 58.57 18.54 29 13944 9649 90604825
Device delivery system issue 57.61 18.54 18 13955 1760 90612714
Urinary tract infection 56.63 18.54 137 13836 305495 90308979
Device defective 56.53 18.54 21 13952 3465 90611009
Lymphopenia 53.53 18.54 37 13936 22844 90591630
Maternal exposure timing unspecified 51.76 18.54 36 13937 22447 90592027
Campylobacter infection 50.98 18.54 15 13958 1197 90613277
Joint swelling 47.27 18.54 10 13963 503290 90111184
Neutropenia 46.19 18.54 105 13868 224799 90389675
JC polyomavirus test positive 45.12 18.54 15 13958 1787 90612687
Pneumonia 44.30 18.54 205 13768 637854 89976620
Systemic lupus erythematosus 44.13 18.54 3 13970 361893 90252581
Myelitis 43.02 18.54 15 13958 2063 90612411
Agranulocytosis 41.60 18.54 38 13935 34964 90579510
Disease recurrence 39.24 18.54 38 13935 37615 90576859
Glossodynia 38.27 18.54 3 13970 321776 90292698
Immune reconstitution inflammatory syndrome 36.54 18.54 19 13954 7000 90607474
Contraindicated product administered 35.38 18.54 4 13969 320135 90294339
Off label use 34.75 18.54 74 13899 1102178 89512296
Drug hypersensitivity 33.17 18.54 15 13958 463594 90150880
Wound 32.95 18.54 4 13969 302976 90311498
Balance disorder 32.92 18.54 56 13917 97024 90517450
Myalgia 32.91 18.54 79 13894 175046 90439428
Ataxia 32.70 18.54 25 13948 18017 90596457
Neutropenic sepsis 32.59 18.54 25 13948 18105 90596369
Rheumatoid arthritis 32.44 18.54 8 13965 362606 90251868
Muscular weakness 32.36 18.54 87 13886 206579 90407895
Hypoaesthesia 32.16 18.54 114 13859 314096 90300378
Gait disturbance 31.51 18.54 100 13873 260396 90354078
Immunoglobulins decreased 30.85 18.54 11 13962 1615 90612859
Feeling abnormal 29.89 18.54 74 13899 167161 90447313
Swelling 29.29 18.54 14 13959 419044 90195430
Hemiparesis 29.25 18.54 30 13943 31789 90582685
SARS-CoV-2 test positive 28.41 18.54 19 13954 11109 90603365
Hemianopia 28.20 18.54 11 13962 2071 90612403
Dextrocardia 27.91 18.54 5 13968 40 90614434
Menstrual discomfort 26.40 18.54 4 13969 9 90614465
Therapy interrupted 25.63 18.54 35 13938 50073 90564401
Abdominal discomfort 25.12 18.54 22 13951 477306 90137168
Therapeutic product effect decreased 25.06 18.54 6 13967 277565 90336909
Drug interaction 24.91 18.54 6 13967 276447 90338027
Injection site haemorrhage 24.77 18.54 26 13947 28292 90586182
Product leakage 24.74 18.54 9 13964 1399 90613075
Helicobacter infection 24.64 18.54 3 13970 226847 90387627
Product temperature excursion issue 24.55 18.54 8 13965 895 90613579
Influenza 24.22 18.54 61 13912 139203 90475271
Device issue 23.87 18.54 26 13947 29511 90584963
Secondary progressive multiple sclerosis 23.74 18.54 9 13964 1570 90612904
Demyelination 23.48 18.54 15 13958 8125 90606349
Anosognosia 22.64 18.54 11 13962 3511 90610963
Temperature intolerance 22.53 18.54 17 13956 12013 90602461
JC virus infection 22.14 18.54 10 13963 2709 90611765
Acute kidney injury 21.93 18.54 11 13962 320376 90294098
Malignant melanoma 21.86 18.54 17 13956 12559 90601915
Adenocarcinoma of colon 21.84 18.54 10 13963 2796 90611678
Wheezing 21.78 18.54 5 13968 238075 90376399
Paraparesis 21.40 18.54 10 13963 2928 90611546
Product supply issue 21.23 18.54 10 13963 2982 90611492
Discomfort 21.02 18.54 8 13965 274327 90340147
Intentional product use issue 20.98 18.54 4 13969 216888 90397586
Inferior vena cava syndrome 20.71 18.54 4 13969 50 90614424
Injury 20.50 18.54 3 13970 197346 90417128
Ectopic pregnancy 20.47 18.54 10 13963 3231 90611243
Osteoarthritis 20.28 18.54 3 13970 195727 90418747
Congenital diaphragmatic hernia 19.61 18.54 5 13968 233 90614241
Oropharyngeal pain 19.55 18.54 50 13923 115137 90499337
Vaginitis gardnerella 19.40 18.54 4 13969 71 90614403
Gingivitis ulcerative 19.37 18.54 5 13968 245 90614229
Confusional state 18.90 18.54 19 13954 386186 90228288
Product use issue 18.85 18.54 14 13959 329905 90284569
Concomitant disease aggravated 18.79 18.54 15 13958 11503 90602971
Intentional dose omission 18.62 18.54 18 13955 17765 90596709

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 160.24 22.68 65 6238 14199 42600833
Pyrexia 146.43 22.68 230 6073 393812 42221220
Influenza like illness 132.18 22.68 73 6230 31767 42583265
Pneumonia 116.44 22.68 216 6087 421933 42193099
Febrile neutropenia 109.98 22.68 136 6167 185567 42429465
Multiple sclerosis 100.57 22.68 39 6264 7559 42607473
Neutropenic sepsis 84.33 22.68 43 6260 15903 42599129
Chills 67.27 22.68 76 6227 93990 42521042
Accidental exposure to product 63.95 22.68 39 6264 20354 42594678
Expanded disability status scale score increased 60.84 22.68 14 6289 440 42614592
Disease progression 51.66 22.68 83 6220 143573 42471459
Lymphocyte count decreased 48.48 22.68 37 6266 27772 42587260
Central nervous system lesion 46.83 22.68 23 6280 7847 42607185
Blood immunoglobulin G decreased 45.88 22.68 16 6287 2298 42612734
Drug dose omission by device 43.59 22.68 20 6283 5866 42609166
Injection related reaction 41.83 22.68 11 6292 605 42614427
Lower respiratory tract infection 41.45 22.68 40 6263 41166 42573866
Incorrect dose administered by device 39.51 22.68 15 6288 2741 42612291
Blood immunoglobulin M decreased 38.12 22.68 11 6292 855 42614177
Herpes zoster 37.72 22.68 37 6266 38840 42576192
Second primary malignancy 37.08 22.68 21 6282 9554 42605478
Blood immunoglobulin A decreased 35.83 22.68 10 6293 689 42614343
Neutropenia 34.71 22.68 85 6218 199346 42415686
Device malfunction 34.65 22.68 22 6281 12305 42602727
Gait disturbance 32.98 22.68 55 6248 97945 42517087
Hypogammaglobulinaemia 32.87 22.68 21 6282 11870 42603162
Infection 32.63 22.68 59 6244 112009 42503023
Device delivery system issue 27.81 22.68 9 6294 1028 42614004
Normal newborn 27.04 22.68 7 6296 362 42614670
Tumour lysis syndrome 27.03 22.68 24 6279 22207 42592825
Hepatitis B reactivation 26.10 22.68 13 6290 4565 42610467
Device leakage 25.58 22.68 17 6286 10268 42604764
Product storage error 24.34 22.68 17 6286 11123 42603909
Optic neuritis 24.32 22.68 12 6291 4130 42610902

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 365.69 17.90 157 12767 50083 110526292
Influenza like illness 273.19 17.90 154 12770 88258 110488117
Pyrexia 268.40 17.90 418 12506 897847 109678528
Expanded disability status scale score increased 220.91 17.90 44 12880 874 110575501
Chills 211.01 17.90 176 12748 190404 110385971
Pneumonia 151.07 17.90 322 12602 876392 109699983
Multiple sclerosis 144.20 17.90 67 12857 25631 110550744
Febrile neutropenia 140.90 17.90 179 12745 316588 110259787
COVID-19 119.35 17.90 145 12779 244915 110331460
Neutropenic sepsis 112.64 17.90 60 12864 30686 110545689
Blood immunoglobulin G decreased 98.25 17.90 33 12891 5367 110571008
Hypogammaglobulinaemia 96.30 17.90 47 12877 20029 110556346
Abortion spontaneous 95.81 17.90 56 12868 34226 110542149
Central nervous system lesion 85.53 17.90 40 12884 15513 110560862
Injection related reaction 78.64 17.90 21 12903 1557 110574818
Progressive multifocal leukoencephalopathy 73.00 17.90 42 12882 24914 110551461
Neutropenia 65.72 17.90 139 12785 374481 110201894
Disease progression 63.24 17.90 107 12817 243927 110332448
Lymphocyte count decreased 61.40 17.90 52 12872 57191 110519184
Accidental exposure to product 61.11 17.90 49 12875 49959 110526416
Device malfunction 56.64 17.90 36 12888 25522 110550853
Lymphopenia 54.78 17.90 42 12882 40128 110536247
Headache 52.68 17.90 223 12701 882154 109694221
B-lymphocyte count decreased 51.44 17.90 16 12908 2039 110574336
Maternal exposure during pregnancy 47.49 17.90 97 12827 254786 110321589
Blood immunoglobulin M decreased 47.37 17.90 15 12909 2026 110574349
Drug dose omission by device 46.69 17.90 26 12898 14490 110561885
Drug interaction 46.66 17.90 3 12921 500180 110076195
Breast cancer 45.46 17.90 37 12887 38505 110537870
Campylobacter infection 45.11 17.90 15 12909 2364 110574011
Second primary malignancy 43.94 17.90 27 12897 18041 110558334
Infection 43.48 17.90 116 12808 362084 110214291
Incorrect dose administered by device 38.93 17.90 18 12906 6796 110569579
Gait disturbance 36.35 17.90 92 12832 278116 110298259
Blood immunoglobulin A decreased 34.13 17.90 12 12912 2236 110574139
Ataxia 33.62 17.90 28 12896 30080 110546295
Fatigue 32.65 17.90 248 12676 1215710 109360665
Normal newborn 32.30 17.90 24 12900 21872 110554503
Hemianopia 31.28 17.90 12 12912 2856 110573519
Toxicity to various agents 30.77 17.90 9 12915 480546 110095829
Agranulocytosis 30.73 17.90 37 12887 61723 110514652
Herpes zoster 30.01 17.90 49 12875 108330 110468045
Myelitis 29.95 17.90 12 12912 3201 110573174
Intentional dose omission 27.38 17.90 21 12903 20059 110556316
Muscular weakness 27.22 17.90 77 12847 248391 110327984
Joint swelling 27.08 17.90 9 12915 442836 110133539
Tumour lysis syndrome 27.07 17.90 25 12899 30776 110545599
Device leakage 26.88 17.90 19 12905 16029 110560346
Immune reconstitution inflammatory syndrome 26.69 17.90 19 12905 16207 110560168
Drug ineffective 26.09 17.90 91 12833 1520449 109055926
Paraparesis 25.90 17.90 12 12912 4554 110571821
Squamous cell carcinoma of skin 25.70 17.90 19 12905 17184 110559191
Optic neuritis 25.44 17.90 16 12908 11131 110565244
Myalgia 25.42 17.90 70 12854 222311 110354064
Demyelination 25.27 17.90 15 12909 9414 110566961
Inappropriate schedule of product administration 25.19 17.90 66 12858 203571 110372804
Urinary tract infection 24.67 17.90 89 12835 326193 110250182
Oropharyngeal pain 24.59 17.90 51 12873 135225 110441150
Anosognosia 24.02 17.90 11 12913 4063 110572312
Cytokine release syndrome 23.97 17.90 35 12889 70271 110506104
Illness 23.90 17.90 38 12886 82133 110494242
Malignant melanoma 23.77 17.90 18 12906 16873 110559502
Drug hypersensitivity 23.29 17.90 12 12912 454078 110122297
JC virus infection 21.29 17.90 11 12913 5279 110571096
Off label use 21.15 17.90 97 12827 1500088 109076287
Vaginitis gardnerella 20.67 17.90 4 12920 68 110576307
Lower respiratory tract infection 19.82 17.90 68 12856 243038 110333337
Adenocarcinoma of colon 19.70 17.90 11 12913 6157 110570218
Colitis 19.09 17.90 39 12885 102284 110474091
Invasive ductal breast carcinoma 18.94 17.90 11 12913 6635 110569740
Secondary progressive multiple sclerosis 18.68 17.90 7 12917 1562 110574813
Wrong technique in device usage process 18.55 17.90 11 12913 6890 110569485
HER2 positive breast cancer 18.50 17.90 5 12919 388 110575987
Muscle strength abnormal 18.35 17.90 5 12919 400 110575975
Natural killer cell count decreased 17.93 17.90 4 12920 139 110576236

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FA02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
CD20 (Clusters of Differentiation 20) inhibitors
ATC L04AG12 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Monoclonal antibodies
FDA MoA N0000175078 CD20-directed Antibody Interactions
MeSH PA D000970 Antineoplastic Agents
FDA EPC N0000175657 CD20-directed Cytolytic Antibody
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug

Related Drugs by ATC class:

L01FA CD20 (Clusters of Differentiation 20) inhibitors 2 drugs
obinutuzumabrituximab
L04AG Monoclonal antibodies 14 drugs
alemtuzumabanifrolumabaxatilimab-csfrbelimumabefalizumabemapalumabinebilizumabmuromonab-CD3natalizumabocrelizumabsibeprenlimab-szsiteprotumumab show all 14 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006
Relapsing multiple sclerosis indication 230372003
Secondary progressive multiple sclerosis indication 425500002 DOID:0050783




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
B-lymphocyte antigen CD20 Surface antigen ANTIBODY BINDING Kd 9.92 IUPHAR DRUG LABEL

External reference:

IDSource
D09314 KEGG_DRUG
4029460 VUID
N0000180305 NUI
4029460 VANDF
CHEBI:749610 CHEBI
CHEMBL1201836 ChEMBL_ID
C527517 MESH_SUPPLEMENTAL_RECORD_UI
6778 IUPHAR_LIGAND_ID
DB06650 DRUGBANK_ID
712566 RXNORM
168892 MMSL
26825 MMSL
d07509 MMSL
013301 NDDF
444607009 SNOMEDCT_US
444609007 SNOMEDCT_US
895672000 SNOMEDCT_US
C1832027 UMLSCUI
8606 INN_ID
M95KG522R0 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
KESIMPTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-1007 INJECTION, SOLUTION 20 mg SUBCUTANEOUS BLA 32 sections